ALEVAI STEM CELL ANTI-DANDRUFF CONDITIONER- pyrithione zinc solution

ALEVAI Stem Cell Anti-Dandruff Conditioner by

Drug Labeling and Warnings

ALEVAI Stem Cell Anti-Dandruff Conditioner by is a Otc medication manufactured, distributed, or labeled by Alevai Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Pyrithione Zinc 2%

Purpose

Anti-dandruff

Uses:

• Helps eliminate reoccurrence of sclap itching, irritation, redness, and falking associated with dandruff. 

Warnings:

For external use only

When using this product

• Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

• condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• For best results use at least twice a week or as directed by a doctor.
• Apply to wet hair after shampooing by gently massaging into hair and scalp, rinse well.

Other information:

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Behentrimonium Methosulfate, Cetearyl Alcohol, Glycerin, Zemea (Corn) Propanediol, Cocous Nucifera (Coconut) Oil, Cetearyl Olivate, Butylene Glycol, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Apigenin, Oleanolic Acid, Biotonyl Tripeptide-1, Argania Spinosa (Argan) Oil, Caprylic/Capric Triglyceride, Hydrolyzed Keratin Protein, Prunus Amygdalus Dulcis (Almond) Oil,Butyropermum Pakii (Shea) Butter, Serenoa Serrulata (Saw Palmetto) Extract, dl-Panthenol, Biotin, Silk Amino Acids, Malus Domestica (Apple) Fruit Cell Culture Extract, Buddleja Davidii Meristem Cell Culture, Xanthan Gum, I-Proline, Spirulina Platensis (Spirulina) Extract, Lamanaria Digitata (Sea Kelp) Extract, Crithmum Maritimum (Sea Fennel) Extract, Leontopodium Alpinum (Edelweiss) Stem Extarct, L-Leucine, L-Valine, Guar Hydroxypopyltrimonium Chloride, L-Threonine, Camellia Sinesis (Green Tea) Extract, Parfum (Fragrance), Phenoxyethanol, Ethylhexylglycerin.

Package Labeling:

INGREDIENTS AND APPEARANCE

ALEVAI STEM CELL ANTI-DANDRUFF CONDITIONER 
pyrithione zinc solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81457-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
CORN (UNII: 0N8672707O)
COCONUT OIL (UNII: Q9L0O73W7L)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
APIGENIN (UNII: 7V515PI7F6)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)
ARGAN OIL (UNII: 4V59G5UW9X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALMOND (UNII: 3Z252A2K9G)
SHEA BUTTER (UNII: K49155WL9Y)
SAW PALMETTO (UNII: J7WWH9M8QS)
PANTHENOL (UNII: WV9CM0O67Z)
BIOTIN (UNII: 6SO6U10H04)
AMINO ACIDS, SILK (UNII: V0L00EX1IA)
APPLE (UNII: B423VGH5S9)
XANTHAN GUM (UNII: TTV12P4NEE)
PROLINE (UNII: 9DLQ4CIU6V)
ARTHROSPIRA PLATENSIS (UNII: 9L3TIH1UUE)
CRITHMUM MARITIMUM WHOLE (UNII: J7IHY79BKY)
LEONTOPODIUM NIVALE SUBSP. ALPINUM ROOT (UNII: SDW6SS1K6I)
LEUCINE (UNII: GMW67QNF9C)
VALINE (UNII: HG18B9YRS7)
THREONINE (UNII: 2ZD004190S)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81457-123-00	236 mL in 1 CYLINDER; Type 0: Not a Combination Product	02/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	02/01/2021

Labeler - Alevai Products LLC (117842557)